Registration Dossier
Registration Dossier
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EC number: 274-765-6 | CAS number: 70693-39-9
PBT assessment
Administrative data
PBT assessment: overall result
- PBT status:
- the substance is not PBT / vPvB
- Justification:
The PBT assessment for Monopentaerythritol tetraesters and dipentaerythritol hexaesters of valeric, heptanoic and nonanoic acids acids is based on the criteria set out in the “Guidance on information requirements and chemical safety assessment, Chapter R.11: PBT Assessment” (ECHA, 2017).
Persistency assessment
The hazard assessment is based on the data currently available. New studies with the registered substance and/or other member substances of the polyol esters category will be conducted in the future. The finalised studies will be included in the technical dossier as soon as they become available and the hazard assessment will be re-evaluated accordingly.
Monopentaerythritol tetraesters and dipentaerythritol hexaesters of valeric, heptanoic and nonanoic acids is considered to be readily biodegradable. A degradation rate of 75 - 96 % was determined in studies according to OECD 301. Thus, the substance does not meet the screening criterion for persistence and is not considered to be P or vP.
Bioaccumulation
Monopentaerythritol tetraesters and dipentaerythritol hexaesters of valeric, heptanoic and nonanoic acids is readily biodegradable and therefore it is considered to be not P and vP. Therefore, no B-assessment was carried out since it is only required if the substance fulfills the P or vP criteria, according to the guideline (Guidance on Information Requirements and Chemical Safety Assessment Chapter R.11: PBT/vPvB assessment, 2017).
Toxicity
The hazard assessment is based on the current data available. A new long-term fish toxicity study (OECD 210) is requested for the registered substance based on the ECHA decision on a compliance check (decision number CCH-D-2114588821-38-01/F). The long-term fish toxicity study could not be finalised until now due to the reasons explained under the respective endpoint (see chapter 6.1.2). The finalised study will be submitted later based on ECHA decision number CCH-D-2114588821-38-01/F. The aquatic toxicity will be re-evaluated in the update of this dossier as soon as the final long-term fish toxicity study will be available.
Monopentaerythritol tetraesters and dipentaerythritol hexaesters of valeric, heptanoic and nonanoic acids the available acute effect concentrations are > 0.1 mg/L (fish, aquatic invertebrates, algae) and the chronic effect concentration (daphnia, algae) is ≥ 0.01 mg/L. The substance is not classified as carcinogenic (category 1A or 1B), germ cell mutagenic (category 1A or 1B) or toxic for reproduction (category 1A, 1B or 2) according to Regulation (EC) No 1272/2008. In addition, the substance shows no specific target organ toxicity after repeated exposure (STOT RE category 1 or 2) according to Regulation (EC) No 1272/2008. The substance is readily biodegradable indicating no peristance. Therefore, the criteria set out in Annex X of Regulation (EC) No 1907/2006 are not met and the test substance is not considered to meet the T criterion.
Conclusion
In conclusion, the substance is not PBT/vPvB.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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